FDA’s National Center for Toxicological Research (NCTR) awards Xybion a multi-year contract for COTS Preclinical Data Management System software
LAWRENCEVILLE, New Jersey – Oct. 10, 2019 – Xybion Corporation, a US-based leading global technology provider for companies operating in the highly regulated industries, announced today that U.S. Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR) awarded a multi-year contract to Xybion. After a competitive RFP process titled COTS “Pre-Clinical Data Management System” Software. NCTR selected Xybion’s Pristima® for various toxicology functions and Savante™ for producing CDISC SEND format data to replace the organization’s existing data management system with a modern, integrated and comprehensive solution.
Xybion’s Pristima® and Savante™ were selected through FDA’s competitive sourcing program amongst multiple vendor proposals and the award includes licensing, implementation and validation services, utilizing Xybion’s expert staff to install, train and validate the Pristima Suite at NCTR. Dr. Pradip K. Banerjee, Chairman and CEO of Xybion said “We are delighted to have the privilege of working with FDA’s NCTR division to support its mission of promoting and protecting public health of our country.” Dr. Banerjee further stated “This is an important win for Xybion, strengthening our commitment to support and improve research and development in the Federal Government. Xybion is dedicated to providing high-quality, transformational services and solutions to help our customers solve their most complex challenges.”
Scope of the awarded contract includes:
- Study management and in-vivo data management for general and reproductive toxicology
- Clinical pathology management
- Necropsy and Pathology management
- Pharmacy inventory and formulations
- SEND dataset production
- ECTD tables production
- System installation and training
- Expert System validation
“We are thrilled to partner with the FDA and welcome its scientific team to the Xybion Pristima community. We are excited to deliver industry-leading study management, informatics and analytics solution to NCTR to facilitate and expedite the research of innovative new products and medicines” stated Kamal Biswas, Xybion’s President and COO.
Xybion™ is a leading software, services and consulting company dedicated to helping corporations solve business problems.
Through intelligently designed systems and business processes, we help companies become more efficient, reduce costs and manage compliance, regulatory adherence and risk. Serving more than 150 customers in 16 countries. Xybion has the global scale and expertise to bring employees around the world together to manage complex business processes and improve program administration.
Xybion business segments include life sciences, workplace health, manufacturing, government and enterprise solutions.
We put our expertise in action every day to help companies transform the digital workplace. Our unique solutions focus on regulatory compliance, GRC, quality management, GLP, integrated preclinical lab management, early-stage drug discovery, content migration and systems validation. Since its founding in 1977, Xybion Corporation has supported, through software, services and consulting, 100% of the top 20 global life sciences companies.